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Last Updated: November 20, 2019

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KYPROLIS Drug Profile

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Which patents cover Kyprolis, and what generic alternatives are available?

Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and seven patent family members in forty countries.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

Drug patent expirations by year for KYPROLIS
Drug Prices for KYPROLIS

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Recent Clinical Trials for KYPROLIS

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SponsorPhase
AmgenPhase 4
Bristol-Myers SquibbPhase 1
PhylogenyPhase 1

See all KYPROLIS clinical trials

Recent Litigation for KYPROLIS

Identify potential future generic entrants

District Court Litigation
Case NameDate
CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA2019-05-23
Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical, Inc.2019-01-11
Onyx Therapeutics, Inc. v. CIPLA Limited2018-04-20

See all KYPROLIS litigation

Pharmacology for KYPROLIS
Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
Synonyms for KYPROLIS
(2S)-4-methyl-N-[(2S)-1-[[(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]-2-[[(2S)-2-[(2-morpholin-4-ylacetyl)amino]-4-phenylbutanoyl]amino]pentanamide
(2S)-N-((1S)-1-Benzyl-2-(((1S)-3-methyl-1-(((2R)-2-methyloxiran-2-yl)carbonyl)butyl)amino)-2-oxoethyl)-4-methyl-2-(((2S)-2-((morpholin-4-ylacetyl)amino)-4-phenylbutanoyl)amino)pentanamide
(2S)-N-[(1S)-1-benzyl-2-[[(1S)-3-methyl-1-[(2R)-2-methyloxirane-2-carbonyl]butyl]amino]-2-oxo-ethyl]-4-methyl-2-[[(2S)-2-[(2-morpholinoacetyl)amino]-4-phenyl-butanoyl]amino]pentanamide
(Alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phe nylalaninamide
(alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phenylalaninamide
(alphaS)-alpha-[[2-(4-Morpholinyl)acetyl]amino]benzenebutanoyl-L-leucyl-N-[(1S)-3-methyl-1-[[(2R)-2-methyl-2-oxiranyl]carbonyl]butyl]-L-phenylalaninamide
(S)-4-methyl-N-((S)-1-(((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide
(S)-4-Methyl-N-((S)-1-((S)-4-Methyl-1-((R)-2- Methyloxiran-2-yl)-1 -oxopentan-2-ylaMino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-MorpholinoacetaMido)-4-phenylbutanaMido)pentanaMide
72X6E3J5AR
868540-17-4
AB0008111
AB01565867_02
AC-27051
AK546882
AKOS025401910
AN-217
AOB87759
AS-17059
BC251806
BDBM50277889
BLMPQMFVWMYDKT-NZTKNTHTSA-N
C40H57N5O7
Carfilzomib
Carfilzomib (JAN/USAN/INN)
Carfilzomib (PR-171)
Carfilzomib [USAN:INN]
Carfilzomib; PR171
Carfilzomib?PR-171?/Kyprolis
Carfilzomib(PR171)
CAS-868540-17-4
CHEBI:65347
CHEMBL451887
CS-0984
CS-W004540
D08880
DB08889
DSSTox_CID_28616
DSSTox_GSID_48690
DSSTox_RID_82886
DTXSID4048690
EX-A2037
FT-0696769
GTPL7420
HY-10455
J-501773
KB-75946
KS-00000SR1
Kyprolis (TN)
L-Phenylalaninamide, (alphaS)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-L-leucyl-N-((1S)-3-methyl-1-(((2R)-2-methyloxiranyl)carbonyl)butyl)-
MLS006011102
MolPort-027-950-907
N-{(2S)-2-[(morpholin-4-ylacetyl)amino]-4-phenylbutanoyl}-L-leucyl-N-{(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl}-L-phenylalaninamide
NCGC00249613-01
NCGC00249613-02
NCGC00249613-03
ONO-7057
PR-171
PX-171-007
QCR-96
RL05381
S-7798
s2853
SB16813
SC-91032
SCHEMBL85165
SMR004660024
SR-01000941582
SR-01000941582-1
SW218090-2
Tox21_113079
Tox21_113079_1
UNII-72X6E3J5AR
Y0441
ZINC49841054
Paragraph IV (Patent) Challenges for KYPROLIS
Tradename Dosage Ingredient NDA Submissiondate
KYPROLIS POWDER;INTRAVENOUS carfilzomib 202714 2018-11-28
KYPROLIS POWDER;INTRAVENOUS carfilzomib 202714 2017-10-05
KYPROLIS POWDER;INTRAVENOUS carfilzomib 202714 2016-07-20

US Patents and Regulatory Information for KYPROLIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for KYPROLIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 16C0017 France   Start Trial PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 20151123
1781688 CA 2016 00014 Denmark   Start Trial PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688 PA2016010,C1781688 Lithuania   Start Trial PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688 C 2016 014 Romania   Start Trial PRODUCT NAME: CARFILZOMIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1060; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1060; DATE OF FIRST AUTHORISATION IN EEA: 20151119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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